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Comparison of propofol and fentanyl with propofol and ketamine in sedation and analgesia in trauma patients

Comparison of propofol and fentanyl with propofol and ketamine in sedation and analgesia in trauma patients

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016112224606N2
Enrollment
132
Registered
2016-12-07
Start date
2016-11-10
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower limb injury - Upper limb injury. Unspecified injury of lower limb, level unspecified injury of NOS - Unspecified injury of upper limb , level unspecified injury of arm NOS

Interventions

Intervention 1: Second group received 0.5 mg/kg propofol and 1 mg/kg ketamine. Intervention 2: First group received 0.5mg/kg propofol and 1 µg/kg fentanyl.
Treatment - Drugs
Second group received 0.5 mg/kg propofol and 1 mg/kg ketamine
First group received 0.5mg/kg propofol and 1 µg/kg fentanyl

Sponsors

Vice chancellor for researche, Mazandaran University of Medical Siences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: inclusion criteria: 1. Age between 18 and 60 years, have indicated a painful procedure and this treatment included painful reduction of dislocation and fractures can be done in an emergency. 2 Persons according to the American Society of Anesthesiologists Physical Status Classification (ASA) class 1 and 2 have Exclusion criteria: 1 - persons under 18 years and above 60 years of age 2- people with Anesthesiologists Physical Status Classification (ASA) class more than two 3-people with kidney and liver disease 4-person with alcohol consumption 5-people addicted to drugs 6- pregnant and lactating women 7- those who have contraindications to the use of ketamine and propofol and fentanyl

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Sedation. Timepoint: Before intervention,5 minutes after intervention, 15minutes after intervention, 30 minutes after intervention, 120 minutes after intervention. Method of measurement: sedation rate is classified by the joint commission(TJC). Grade 1 (Minimal sedation): patients obey orders, but patient consciousness has been disrupted. Grade 2 (Moderate sedation): the patient wakes up in responding to touch and has a withdrawal reflex to pain. Grade 3 (Deep sedation): patient wakes up with recurrent painful stimulation and cannot keep his/her airway by own. Grade 4 (General anesthesia): patient not respond to repeated painful provocations and requires mechanical ventilation, and cardiovascular status can also be disrupted.;Pain. Timepoint: Before intervention,5 minutes after intervention, 15minutes after intervention, 30 minutes after intervention, 120 minutes after intervention. Method of measurement: Pain is rated according to numerical scale 0 to 10, so 10 is the worst pain condition and 0 is no pain condition.

Secondary

MeasureTime frame
Oxygen Saturation. Timepoint: Before intervention, 5 minutes after intervention, 15 minutes after intervention, 30 minutes after intervention, 120 minutes after intervention. Method of measurement: Puls oxymeter.;Heart Rate. Timepoint: Before intervention, 5 minutes after intervention, 15 minutes after intervention, 30 minutes after intervention, 120 minutes after intervention. Method of measurement: number per minutes.;Respiratory rate. Timepoint: Before intervention, 5 minutes after intervention, 15 minutes after intervention, 30 minutes after intervention, 120 minutes after intervention. Method of measurement: number per minutes.;Blood pressure. Timepoint: Before intervention, 5 minutes after intervention, 15 minutes after intervention, 30 minutes after intervention, 120 minutes after intervention. Method of measurement: sphygmomanometer mmhg.;Vomiting. Timepoint: Before intervention, 5 minutes after intervention, 15 minutes after intervention, 30 minutes after intervention, 120 minutes after intervention. Method of measurement: Observation.;Sialorrhea. Timepoint: Before intervention, 5 minutes after intervention, 15 minutes after intervention, 30 minutes after intervention, 120 minutes after intervention. Method of measurement: Observation.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamed Aminiahidashti

Mazandaran University of Medical Sciences

h.aminiahidashti@mazums.ac.ir+98 11 3336 1700

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026